Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics?
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Assaf-Harofeh Medical Center.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Assaf-Harofeh Medical Center
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00732966
First received: August 10, 2008
Last updated: August 11, 2008
Last verified: August 2008
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Purpose
Most Angiotensin receptor blocker's (ARBs) are metabolized by cytochrome P4502C9 (CYP2C9), one of the major isoforms of the cytochrome P450 in human liver microsome. The purpose of this study is to evaluate whether CYP2C9 polymorphism has a significant clinical influence on the blood pressure lowering effect of losartan and valsartan. Weather there is a genetic importance in choosing the right ARB for the right patient.
| Condition | Intervention |
|---|---|
|
Hypertension |
Drug: losartan Drug: valsartan |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Ocsaar and CYP2C9 Ploymorphism, Is There a Connection Between Pharmacokinetics, Pharmacodynamics and Pharmacogenetics? |
Resource links provided by NLM:
Further study details as provided by Assaf-Harofeh Medical Center:
Primary Outcome Measures:
- Blood pressure lowering effect of losartan and valsartan in patients with different CYP2C9 allels [ Time Frame: one month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- losartan/E-3174 ratio in different allelic groups of CYP2C9 [ Time Frame: one month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2008 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Hypertensive patients will be treated with losartan for one months
|
Drug: losartan
with losartan 50 mg once daily for one month
Drug: valsartan
valsartan 160 mg once daily
|
|
Experimental: 2
Hypertensive patients will be treated with valsartan
|
Drug: losartan
with losartan 50 mg once daily for one month
Drug: valsartan
valsartan 160 mg once daily
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The study will include 30 patients with the 3 most prevalent alleles of CYP2C9 *1, *2 and*3, 10 patients of each group.
Exclusion Criteria:
- Patients treated with losartan or valsartan prior to their enrollment to the study,
- Patients with BP below 140 systolic or 90 diastolic in an ambulatory 24 hours BP monitoring, acute coronary syndrome during the 6 months previous to the study,
- Renal failure with creatinin levels above 1.5 mg/dL, hyperkalemia (K > 5 mg/dL),
- Hematologic or solid malignancies or pregnancy.
-
Patients will also be excluded from the study if they are known to use one of the drugs inducing or inhibiting the CYP2C9, such as
- rifampicin carbamazepine,
- ethanol,
- phenobarbitone,
- fluconazole,
- amiodarone,
- trimethoprim,
- fluvastatin,
- cimetidine
- chloramphenicol.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732966
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732966
Contacts
| Contact: Ronit Koren Peleg, MD | 972-524-535024 | ronitkoren@gmail.com | |
| Contact: Ahuva Golik, Prof | 972-577-345242 | golik@asaf.health.gov.il |
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
| Principal Investigator: | Ronit Koren Peleg, MD | Department of Internal Medicine A , Research & Development unit Assaf Harofeh Medical Center, Zerifin, affiliated to Sackler School of Medicine, Tel Aviv, Israel |
More Information
| Responsible Party: | Koren Peleg Ronit MD, Assaf-Harofeh Medical Center internal medicine A |
| ClinicalTrials.gov Identifier: | NCT00732966 History of Changes |
| Other Study ID Numbers: | ronit3 |
| Study First Received: | August 10, 2008 |
| Last Updated: | August 11, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Assaf-Harofeh Medical Center:
|
cyp2c9 losartan pharmacogenetics pharmacokinetics pharmacodynamics |
Additional relevant MeSH terms:
|
Losartan Valsartan Anti-Arrhythmia Agents Antihypertensive Agents |
Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016